Cleared Traditional

K243834 - NobelZygoma TiUltra Implant system

K243834 is the FDA 510(k) clearance for NobelZygoma TiUltra Implant system by Nobel Biocare AB. It is a Class 2 Dental device (product code DZE) cleared through the Traditional 510(k) pathway after a 255-day FDA review.

K243834 · Nobel Biocare AB · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Aug 2025
Decision
255d
Days
Class 2
Risk

K243834 is an FDA 510(k) clearance for the NobelZygoma TiUltra Implant system. Classified as Implant, Endosseous, Root-form (product code DZE), Class II - Special Controls.

Submitted by Nobel Biocare AB (Goteborg, SE). The FDA issued a Cleared decision on August 25, 2025 after a review of 255 days - an extended review cycle.

This device falls under the Dental FDA review panel, regulated under 21 CFR 872.3640 - the FDA dental device regulatory framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Dental review framework, consistent with the majority of Class II 510(k) submissions.

View all Nobel Biocare AB devices

Submission Details

510(k) Number K243834 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 13, 2024
Decision Date August 25, 2025
Days to Decision 255 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
128d slower than avg
Panel avg: 127d · This submission: 255d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code DZE Implant, Endosseous, Root-form
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 872.3640
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Dental devices follow this clearance model.

Regulatory Peers - DZE Implant, Endosseous, Root-form

All 588
Devices cleared under the same product code (DZE) and FDA review panel - the closest regulatory comparables to K243834.
Paltop Dental Implant System
K243983 · Paltop Advanced Dental Solutions, Ltd. · Sep 2025
S.I.N. Dental Implant System
K251262 · S.I.N. Implant System Ltda · Sep 2025
JDEvolution Plus L and JDEvolution Plus LE
K251148 · Jdentalcare Srl · Sep 2025
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K251647 · Dentsply Sirona, Inc. · Aug 2025
Neodent Implant System - Zirconia Implant System
K250271 · JJGC Ind?stria e Com?rcio de Materiais Dent?rios S.A. · Aug 2025
S.I.N. Dental Implant System
K251046 · S.I.N. Implant System Ltda · Aug 2025